Theranos Email Trail Shows Regulatory Concerns In 2012

Until October the company and its chief executive Elizabeth Holmes were the darlings of the startup world, but the dream began to unravel following greater scrutiny of operations. Now it has been revealed that a military official became concerned about regulatory compliance years ago, writes Carolyn Johnson for The Washington Post.

Theranos still waiting on FDA approval for blood tests

The official launched a formal inquiry with the Food and Drug Administration after concerns were raised about plans to distribute tests without FDA clearance. This first episode occurred in 2012, and the controversy has resurfaced this year.

Holmes managed to get four-star general James Mattis to cover up those concerns in 2012, but the issue won’t go away. Scientists have been left wondering why Theranos won’t submit its methods to peer review, and the company has been forced to stop offering the majority of its tests due to concerns about regulatory approval.

The company’s revolutionary methods apparently use only a few drops of blood to carry out tests that usually need a full vial, and Theranos has been valued at $9 billion. In 2012 the tests were being reviewed for military programs, but they are now commercially available. Due to FDA concerns all tests have been withdrawn, apart from the herpes test.

Holmes fails to convince scientific community on tests

As previously reported by ValueWalk, Theranos became a media sensation and Holmes was featured on the covers of Fortune, Forbes and Inc. in recent years. Although Holmes had powerful friends and allies, they mainly came from government and military positions.

A year after Mattis pushed for testing of Theranos devices, he joined the company’s board of directors. Holmes surrounded herself with powerful ex-officials, but ran into trouble when it came to impressing the scientific community.

After meeting at an event in 2011, Mattis told Holmes that he wanted to test Theranos technology for use on the battlefield. He emailed her telling her to get in touch if they needed to talk, and after the military expert filed an investigation with the FDA she did just that.

Emails highlight modus operandi of Holmes and Theranos

“I would very much appreciate your help in getting this information corrected with the regulatory agencies,” Holmes wrote in the e-mail to Mattis. “Since this misinformation came from within DoD, it will be invaluable if this information is formally corrected by the right people in DoD.”

Mattis forwarded the emails to other military officials in an attempt to push through testing, but was ultimately rebuffed. He left the Marine Corps two months later, before joining the Theranos board of directors.

Holmes used her contacts in the military to silence critics of Theranos devices on that occasion, but she must surely have known that regulators would want to test the devices at some point. Instead of submitting the devices to peer review and proper scrutiny, Holmes apparently believed that she could charm the medical world into accepting a new device that no one had properly assessed for safety or utility.

Theranos story began to unravel in October this year

ValueWalk covered the current struggles of a former media darling in October, providing a glimpse into the inner workings of a company that so many believed would revolutionize health care. All of the elements appeared to be in place: a young, female entrepreneur with an interesting personal narrative who had come up with disruptive technology that would improve millions of people’s lives.

However an investigation revealed that far from revolutionizing healthcare, the company has been forced to carry out the majority of its work using conventional equipment after the FDA ruled that its test modules were unapproved medical devices. A previous agreement to install blood testing centers in Walgreens stores was put on hold following the news.

After gaining influential backers without ever revealing the science behind the testing devices, the Theranos story began to unravel after the medical community began to question the lack of data. Many scientists have expressed their willingness to test Theranos products if only the company would let them.

So far the company has claimed that it doesn’t want to submit its devices to peer review because of fears over other companies stealing its technology, but the excuse has worn thin. Unless there is a dramatic turnaround and a new wave of testing that leads to FDA approval, it is hard to see how Theranos can recover from its current situation.